The Food and Drug Administration (FDA) on Tuesday announced a new initiative titled “Operation Stork Speed” aimed at ...

Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...

The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the ...

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for ...

Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.

The US Food and Drug Administration (FDA) accepted and granted Priority Review designation for Bayer’s (BAYN: DE) supplemental new drug application (sNDA) for a new indication for Kerendia (finerenone ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of ...

After the contentious Senate confirmation of Robert F. Kennedy Jr., another crucial governmental health leadership ...

Questioned by senators at a Thursday hearing, President Trump's FDA nominee said he would reevaluate which scientific topics ...

FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...

Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for ...